LEVEMIR insulin injection recalled for lack of sterility assurance
LEVEMIR injectable insulin is being recalled nationwide due to insanitary facility conditions that compromise sterility assurance. FDA inspection identified conditions that may affect product safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable medication where lack of sterility assurance has been identified but no illnesses or injuries have been reported. This fits the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmacy Innovations is recalling LEVEMIR-STS 100U/ML injectable insulin (1 mL vials) nationwide due to lack of assurance of sterility. An FDA inspection of the manufacturing facility in Erie, Pennsylvania revealed insanitary conditions that may compromise the sterility of the product.
Sterile injectable products must be manufactured under strictly controlled conditions to prevent contamination. Insanitary facility conditions present a risk that injectable insulin could become contaminated with harmful microorganisms, potentially causing serious infections if used.
Consumers who have this product should contact their healthcare provider or pharmacy immediately. If you have any of this product, do not use it and return it to your pharmacy or the manufacturer for proper disposal.
The recalled product
- Product
- LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable Insulin
- Hazard
- lack-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- t20221116@36
Distribution
Distributed nationwide across the United States.
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